Device for introduction of long item

ABSTRACT

Disclosed herein is a device (such as guidewire inserter) for easily and certainly inserting a medical long item having a curved tip into a tube such as catheter and sheath. The guidewire inserter is a tubular member having therein a bore for passage of a guidewire. The tubular member has a slit cutting across the wall thereof over the total length thereof. The tubular member has at the proximal end thereof an aperture, which results from the slit expanding toward the proximal end. The tubular member has at the proximal end of the aperture an open part and a connecting part adjacent thereto for the holder tube. There are a pair of wing-like protruded pieces projecting in the mutually opposite directions at both sides of the open part. The distal end of the tubular member has on its outer surface a pair of protruded rims, which project in the mutually opposite directions with respect to the central axis of the tubular member. When the distal end of the tubular member is connected by insertion into the bore at the proximal end of the tube, such as sheath, the protruded rims come into contact with the inside of the hub.

This application is a continuation of application Ser. No. 11/067,771filed on Mar. 1, 2005, the entire content of which is incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to a device for introduction of a longitem for medical use, such as guidewire and catheter (the device will bereferred to as inserter hereinafter).

BACKGROUND DISCUSSION

It has been common practice to use a guidewire inserter for introductionof a catheter guidewire (long item) into a puncture needle, catheter, orsheath.

The guidewire inserter is used to straighten a guidewire having a curvedtip. It is a cylindrical body made up of a guidewire inlet at itsproximal end, a guidewire outlet at its distal end, and a guidewirepassage connecting the inlet and outlet. It is used in such a way thatthe guidewire outlet is brought into contact with the proximal end ofthe puncture needle, catheter, or sheath, and the guidewire is insertedinto the guidewire inlet and then further inserted into the punctureneedle, catheter, or sheath through the guidewire passage and theguidewire outlet.

The conventional guidewire inserter as mentioned above has thedisadvantage of presenting difficulties in inserting into the inserter aguidewire having a curved tip. The guidewire is so curved as to fit to aspecific part of blood vessel. Therefore, with the conventionalguidewire inserter, it is difficult to inert a guidewire having a curvedtip (in J shape, double-angle shape, or angle shape) into the inserterwhile straightening the curved tip.

In order to address this problem, in JP 7-155382 A, there has beenproposed a guidewire inserter having a groove, which introduces theguidewire, at its proximal end (near the guidewire inlet). This groovehas a V-shaped cross section whose width remains constant in thelongitudinal direction of the guidewire inserter and changes in thethickness direction of the guidewire inserter.

However, the above-mentioned guidewire inserter having a groove at itsproximal end does not permit the recent guidewire with a sharply curvedJ-shape tip to be inserted easily, with the curved tip beingstraightened.

The difficulty in inserting the guidewire into the opening of the rearend of the guidewire inserter may be solved by inserting the rear end ofthe guidewire into the distal end (or the guidewire outlet) of theguidewire inserter and then moving the guidewire inserter to the distalend of the guidewire. This procedure, however, takes a long time to movethe guidewire inserter from the rear end to the distal end of aguidewire longer than 150 cm.

The above-mentioned problem is also involved with the angiographycatheter, which needs a catheter inserter to straighten the curved tipat the time of insertion into the living body.

Another problem with the conventional guidewire inserter is that it isdifficult to connect the distal end (or the guidewire outlet) of theguidewire inserter to the proximal end of the puncture needle, catheter,or sheath. The incomplete or misaligned connection prevents smoothinsertion of the distal end of the guidewire, with its curved tipstraightened.

During operation, it is often necessary to hold both the guidewire andthe guidewire inserter with one hand. It is also necessary to hold boththe guidewire and the guidewire inserter simultaneously in order to takeout the guidewire from the container (or the holder tube) and insert itinto the guidewire inserter. The conventional guidewire inserterprevents handling in such a way, with the result that only the guidewireinserter is pulled off from the holder tube.

SUMMARY

It is a first object of the present invention to provide a device forintroduction of a long item. The device permits easy insertion of amedical long item with a curved tip while straightening the curved tipduring insertion.

It is a second object of the present invention to provide a device forintroduction of a long item. The device permits easy and adequateintroduction of a medical long item with a curved tip into a punctureneedle, catheter, or sheath.

It is a third object of the present invention to provide a device forintroduction of a long item. The device permits easy insertion of amedical long item with a curved tip and also exhibits good handlingproperties such that the device can be held together with the medicallong item simultaneously by one hand.

The present invention to achieve the above-mentioned objects is definedin the following paragraphs (1) to (38).

(1) A device for introduction of a long item for medical use, which is atubular member having a bore for passage of a long item and which has aslit cutting across the wall thereof over the total length thereof,wherein the tubular member has a distal end which is constructed suchthat a part thereof in the circumferential direction projects in thedistal direction and the slit cuts through the projecting part.

(2) The device for introduction of a long item as defined in paragraph(1), wherein the projecting part takes on a mountain-like shape having avertex and slopes in its plan view, and the slit passes through thevertex or slope of the mountain-like shape.

(3) The device for introduction of a long item as defined in paragraphs(1) or (2), wherein the projecting part has a length no shorter than 1mm, particularly 1 to 3 mm.

(4) The device for introduction of a long item as defined in any ofparagraph (1) to (3), wherein the tubular member has at the proximal endthereof an aperture which results from the slit expanding toward theproximal end.

(5) The device for introduction of a long item as defined in paragraphs(4), wherein the aperture roughly takes on a V-shape.

(6) The device for introduction of a long item as defined in any ofparagraphs (1) to (5), wherein d/Dmax is 0.2 to 2.0, where Dmax denotesthe maximum apart distance of the aperture and d denotes the outsidediameter of the long item.

(7) The device for introduction of a long item as defined in any ofparagraphs (1) to (6), wherein the slit tightly closes at least partlyacross the thickness of the wall of the tubular member.

(8) The device for introduction of a long item as defined in any ofparagraphs (1) to (7), wherein the tubular member has a part whoseoutside diameter gradually tapers in going from the proximal to thedistal end.

(9) A device for introduction of a long item for medical use, which is atubular member having a bore for passage of a long item, wherein thetubular member has a plurality of projections on the circumferentialdirection of the distal end thereof so that the distal end thereof isconnected at the proximal end of a tube, with the projections cominginto contact with the inside of the tube at the time of insertion.

(10) The device for introduction of a long item as defined in paragraph(9), wherein the projections are arranged at equiangular intervals alongthe circumferential direction of the tubular member.

(11) The device for introduction of a long item as defined in paragraph(9) or (10), wherein the projections are protruded rims extending in thelongitudinal direction of the tubular member.

(12) The device for introduction of a long item as defined in any ofparagraphs (9) or (11), wherein the projections have the outermostsurface which slopes with respect to the central axis of the tubularmember.

(13) The device for introduction of a long item as defined in paragraph(12), wherein the slope has an angle of 0.5 to 45°.

(14) The device for introduction of a long item as defined in any ofparagraphs (9) or (13), wherein the projections have the outermostsurface which convexly curves.

(15) The device for introduction of a long item as defined in any ofparagraphs (9) or (14), wherein the projections are integrally formedfrom a material which is identical with or different from the materialof the tubular member.

(16) The device for introduction of a long item as defined in any ofparagraphs (9) to (15), wherein the tubular member has at the proximalend thereof an open part at which the bore opens.

(17) The device for introduction of a long item as defined in any ofparagraphs (9) to (16), wherein the tubular member has a slit, whichextends in the longitudinal direction thereof and cuts across the wallthereof.

(18) The device for introduction of a long item as defined in paragraph(17), wherein the slit has at the proximal end thereof an aperture,which results from the width of the slit expanding toward the proximalend.

(19) The device for introduction of a long item as defined in paragraph(17), wherein the slit has at the proximal end thereof an aperture whichresults from the width of the slit expanding toward the proximal end andwhich has a roughly V-shaped aperture communicating with the open part.

(20) The device for introduction of a long item as defined in any ofparagraphs (17) to (19), wherein the slit tightly closes at least partlyacross the thickness of the wall of the tubular member.

(21) The device for introduction of a long item as defined in any ofparagraphs (17) to (20), wherein the projections are formed in pair inthe opposite direction with respect to a plane containing the slit.

(22) The device for introduction of a long item as defined in any ofparagraphs (9) to (21), wherein the projections have a function toprescribe the depth of insertion into the tube.

(23) The device for introduction of a long item as defined in any ofparagraphs (9) to (22), wherein the projections have a function to alignthe tubular member and the tube with each other.

(24) The device for introduction of a long item as defined in any ofparagraphs (9) to (23), wherein the tubular member has a part whoseoutside diameter gradually tapers in going from the proximal to thedistal end.

(25) The device for introduction of a long item as defined in any ofparagraphs (9) to (24), wherein the tubular member has at the proximalend thereof a connecting part capable of connection to the containerholding the long item.

(26) A device for introduction of a long item for medical use, which isa tubular member having a bore for passage of a long item and which hasa slit extending in the longitudinal direction thereof and cuttingacross the wall thereof, wherein the tubular member has at the proximalend thereof a pair of wing-like projections projecting in the mutuallyopposite directions.

(27) The device for introduction of a long item as defined in paragraph(26), wherein the projections assume a flat shape.

(28) The device for introduction of a long item as defined in paragraph(26), wherein the projections assume a shape having a curved part.

(29) The device for introduction of a long item as defined in paragraph(26), wherein the projections assume a shape having a flat part and acurved part.

(30) The device for introduction of a long item as defined in any ofparagraphs (26) to (29), wherein the projections have a length in thelongitudinal direction of the tubular member with 10 to 50% of the totallength of the device for introduction of a long item.

(31) The device for introduction of a long item as defined in any ofparagraphs (26) to (30), wherein the tubular member has at the proximalend thereof an open part at which the bore opens.

(32) The device for introduction of a long item as defined in paragraph(31), wherein the inner surface of the open part has a surface treatmentto reduce friction.

(33) The device for introduction of a long item as defined in any ofparagraph (31) or (32), wherein the region in which the open part isformed and the region in which the projections are formed overlap atleast partly with each other in the longitudinal direction of thetubular member.

(34) The device for introduction of a long item as defined in any ofparagraphs (26) to (33), wherein the slit has at the proximal endthereof an aperture which results from the width of the slit expandingtoward the proximal end.

(35) The device for introduction of a long item as defined in any ofparagraphs (31) to (33), wherein the slit has at the proximal endthereof an aperture which results from the width of the slit expandingtoward the proximal end and which has a roughly V-shaped aperturecommunicating with the open part.

(36) The device for introduction of a long item as defined in any ofparagraphs (26) to (35), wherein the slit tightly closes at least partlyacross the thickness of the wall of the tubular member.

(37) The device for introduction of a long item as defined in any ofparagraphs (26) to (36), wherein the tubular member has a part whoseoutside diameter gradually tapers in going from the proximal to thedistal end.

(38) The device for introduction of a long item as defined in any ofparagraphs (26) to (37), wherein the tubular member has at the proximalend thereof a connecting part capable of connection to the containerholding the long item.

The device according to the present invention makes it possible toeasily insert a long item for medical use, such as guidewire andcatheter with a curved tip, while straightening the curved tip orkeeping the straight shape. Therefore, it permits easy and certaininsertion of a long item for medical use having a curved tip into thebore of a puncture needle, catheter, or sheath.

The device according to the present invention makes it possible toeasily and adequately connect the distal end of a long-item insertingdevice to the proximal end of a tube, such a puncture needle, catheter,and sheath. It also makes it possible to easily and certainly insert amedial long item having a curved tip into the tube from a long-iteminserting device.

The device according to the present invention makes it possible to holdthe medical long item and the long-item inserting device simultaneouslyby one hand. Therefore, it improves handling properties at the time ofmoving a medical long item to a long-item inserting device from acontainer of a medical long item or at the time of inserting a medicallong item into the bore of a puncture needle, catheter, or sheath.

Consequently, the present invention contributes to rapid and adequatemedical practice through easy insertion of a medical long item into thebore of a tube.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view showing the device for introduction of a long itemaccording to the first embodiment of the present invention, with thedevice being used as a guidewire inserter.

FIG. 2 is a side view of the guidewire inserter shown in FIG. 1.

FIG. 3 is a sectional side view of the guidewire inserter shown in FIG.1.

FIG. 4 is a sectional view taken along the line A-A in FIG. 2.

FIG. 5 is a sectional view taken along the line B-B in FIG. 2.

FIG. 6 is a side view showing the device for introduction of a long itemaccording to the second embodiment of the present invention, with thedevice being used as a guidewire inserter.

FIG. 7 is a longitudinal sectional view of the guidewire inserter shownin FIG. 6.

FIG. 8 is a plan view of the guidewire inserter shown in FIG. 6.

FIG. 9 is a sectional view taken along the line A-A in FIG. 6.

FIG. 10 is a sectional view taken along the line B-B in FIG. 6.

FIG. 11 is a sectional view taken along the line C-C in FIG. 6.

FIG. 12 is a diagram illustrating the guidewire inserter (shown in FIG.6) connected to a tube.

FIG. 13 is a side view showing the device for introduction of a longitem according to the third embodiment of the present invention, withthe device being used as a guidewire inserter.

FIG. 14 is a longitudinal sectional view of the guidewire inserter shownin FIG. 13.

FIG. 15 is a plan view of the guidewire inserter shown in FIG. 13.

FIG. 16 is a sectional view taken along the line A-A in FIG. 13.

FIG. 17 is a sectional view taken along the line B-B in FIG. 13.

FIG. 18 is a sectional view taken along the line C-C in FIG. 13.

FIG. 19 is a side view showing the device for introduction of a longitem according to the fourth embodiment of the present invention, withthe device being used as a guidewire inserter.

FIG. 20 is a longitudinal sectional view of the guidewire inserter shownin FIG. 19.

FIG. 21 is a plan view of the guidewire inserter shown in FIG. 19.

FIG. 22 is a sectional side view illustrating how to use the guidewireinserter according to the present invention.

FIG. 23 is a sectional side view illustrating how to use the guidewireinserter according to the present invention.

FIG. 24 is a sectional side view illustrating how to use the guidewireinserter according to the present invention.

FIG. 25 is a sectional side view illustrating how to use the guidewireinserter according to the present invention.

FIG. 26 is a sectional side view illustrating how to use the guidewireinserter according to the present invention.

FIG. 27 is a partly sectional plan view illustrating how to use theguidewire inserter according to the present invention.

FIG. 28 is a sectional side view showing the device for introduction ofa long item according to the fifth embodiment of the present invention,with the device being used as a catheter inserter.

FIG. 29 is a sectional side view illustrating how to use the catheterinserter according to the present invention.

FIG. 30 is a sectional side view illustrating how to use the catheterinserter according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention will be described in more detail with reference to theaccompanying drawings.

First Embodiment

FIG. 1 is a plan view showing the device for introduction of a long itemaccording to the first embodiment of the present invention. The deviceis used as a guidewire inserter. FIGS. 2 and 3 are a side view and asectional side view, respectively, of the guidewire inserter shown inFIG. 1. FIG. 4 is a sectional view taken along the line A-A in FIG. 2.FIG. 5 is a sectional view taken along the line B-B in FIG. 2.

As shown in FIGS. 1 to 5, the guidewire inserter 1 is a tubular member 2having a bore 22 (guidewire passage) inside that permits the guidewire,which is a medical long item, to pass through.

The tubular member 2 includes two parts: a cylindrical part (near theproximal end) having an approximately constant outside diameter, and atapered part 21 having a decreasing outside diameter in going to thedistal end. The tapered part 21 facilitates easy insertion of theguidewire inserter 1.

Incidentally, the tapered part 21 may be uniformly or stepwise taperedover its total length. (Refer to FIGS. 1 and 2.)

The distal end 25 of the tubular member 2 should preferably be taperedto its end. The distal end 25 is inserted into and connected to apuncture needle, a catheter, a hub of a catheter, a connector, or asheath (not shown). It also straightens the curved tip of the guidewire.The tapered shape of the distal end 25 facilitates insertion andconnection.

The bore 22 has its both ends opened at the proximal end and distal endof the tubular member 2. The opening at the proximal end of the tubularmember 2 constitutes the inlet 23 for the guidewire. The opening at thedistal end of the tubular member 2 constitutes the outlet 24 for theguidewire. The inlet 23 and outlet 24 may take on any shape (ellipse andpolygon) although they are round in the figures.

The bore 22 does not necessarily have a constant inside diameter overits total length. The bore 22 shown in FIG. 3 has a larger insidediameter near the proximal end of the tubular member 2.

The inside diameter of the bore 22 should be large enough for theguidewire to pass through. To be concrete, it should preferably be 0.3to 1.5 mm. For use as an inserter for an angiography catheter (mentionedlater), the inside diameter should preferably be 0.3 to 2.5 mm, morepreferably 0.4 to 2.2 mm.

The tubular member 2 may be made of a stiff but somewhat resilientmaterial, such as polyolefin (polyethylene and polypropylene),polyamide, and polycarbonate.

The tubular member 2 has a slit 3 formed over its total length. The slit3 penetrates the wall of the tubular member 2. The slit 3 is straight inits plan view (FIG. 1) and is parallel to the central axis of thetubular member 2.

The slit 3 facilitates insertion of the guidewire because it opens whenthe guidewire is inserted into the bore 22 of the tubular member 2.

As shown in FIG. 4, the slit 3 has a straight cross section. In otherwords, it should tightly close over the entire distance from the bore 22of the tubular member 2 to the outside of the tubular member 2.Alternatively, the slit 3 may have a Y- or V-shaped cross section, inwhich case it closes only at the bore side.

The slit 3 prevents the guidewire from escaping from the bore 22unexpectedly after the guidewire has been inserted into the bore 22,because it tightly closes at least partly across the thickness of thewall.

The slit 3 gradually expands near the proximal end of the tubular member2, thereby constituting an aperture 4, as shown in FIGS. 1 and 5. Theaperture 4 takes on a V-shape in its plan view. The aperture 4facilitates insertion of the guidewire into the bore 22, because itfunctions as a starting point for insertion. In other words, one whowants to insert the guidewire into the inerter may insert the guidewireinto the aperture 4 and then push it into the bore 22. As the guidewireis pushed into the bore 22, the slit 3 opens such that opening graduallymoves to the distal end.

In the illustrated constitution, the aperture 4 is most widely apart atthe proximal end of the tubular member 2. The maximum apart distance(Dmax) of the aperture 4 is not specifically restricted; however, itshould preferably be such that the ratio of d/Dmax (where d is theoutside diameter of the guidewire) is about 0.2 to 2.0, preferably about0.5 to 0.9. The aperture 4 specified above facilitates insertion of theguidewire into the slit 3 through the aperture 4.

The aperture 4 is not specifically restricted in its length in thelongitudinal direction (or the longitudinal direction of the tubularmember 2); however, it should be about 0.1 to 2.5 mm long, preferablyabout 0.1 to 3.0 mm long.

The tubular member 2 has a projection 5 at its distal end. Thisprojection 5 is a distally projecting part of the circumferentialdirection of the tubular member 2. (This part is at the upper side inFIG. 2.) This projection 5 takes on a mountain-like shape, with a vertexand slopes, in its plan view (FIG. 1). The slit 3 passes through thevertex of the mountain-like shape of the projection 5. In other words,the projection 5 is symmetrical with respect to the slit 3. Theprojection may also be formed such that the slit 3 passes through theslope of the mountain-like shape.

The projection 5 contributes to strength and prevents the curved tip ofthe guidewire from being caught by the slit 3 when the curved tip isstraightened at the distal end 25. Therefore, it facilitatesstraightening of the curved tip of the guidewire and also facilitatesinsertion of the guidewire into the puncture needle, catheter, orsheath.

The projection 5 is not specifically restricted in the projecting lengthL1 in the distal direction; however, the projecting length shouldpreferably be no shorter than 1 mm, more preferably about 1 to 3 mm.

Incidentally, the embodiment with the projection 5 may be replaced bythe other one in which the slit 3 parallel to the central axis of thetubular member 2 deviates from the central axis near the distal end 25.In this case, the slit 3 may be formed such that its direction isinclined 20 to 300 with respect to the central axis of the tubularmember 2 at that part away from the distal end 25. The slit 3 formed inthis manner prevents the curved tip from being caught by the slit 3 whenthe curved tip of the guidewire is straightened.

Second Embodiment

FIG. 6 is a side view showing the device for introduction of a long itemaccording to the second embodiment of the present invention. The deviceis used as a guidewire inserter. FIGS. 7 and 8 are respectively alongitudinal sectional view and a plan view of the guidewire insertershown in FIG. 6. FIG. 9 is a sectional view taken along the line A-A inFIG. 6. FIG. 10 is a sectional view taken along the line B-B in FIG. 6.FIG. 11 is a sectional view taken along the line C-C in FIG. 6. FIG. 12is a diagram illustrating the guidewire inserter (shown in FIG. 6)connected to a tube.

As shown in FIGS. 6 to 12, the guidewire inserter 101 is a tubularmember 102 having a bore 122 (guidewire passage) inside that permits theguidewire 108, which is a medical long item, (described later) to passthrough.

The tubular member 102 includes two parts: a cylindrical part (near theproximal end) having an approximately constant outside diameter, and atapered part 121 having a decreasing outside diameter in going to thedistal end. In this embodiment, the tapered part 121 is formed at thedistal end of the tubular member 102. The tapered part 121 facilitateseasy and smooth insertion of the guidewire inserter 101 into the tube110 (mentioned later).

Incidentally, the tapered part 121 may be uniformly or stepwise taperedover its total length. Two or more tapered parts may be formed. In thisembodiment, the tapered part is formed also near the inlet 123 at theproximal end of the tubular member 102.

The distal end (or the tapered part 121) of the tubular member 102 isinserted into and connected to the tube 110, such as a puncture needle,a catheter, a hub of a catheter, a Y-connector, or a sheath (not shown).It also straightens the curved tip 181 of the guidewire 108. The tapereddistal end of the tubular member 102 facilitates insertion into andconnection to the tube 110.

The bore 122 of the tubular member 102 has a roughly circular crosssection. The distal end of the bore 122 opens at the distal end of thetubular member 102, and the proximal end of the bore 122 opens at theopen part 105 (mentioned later). The proximal end opening of the bore122 constitutes the inlet 123 for the guidewire 108, and the distal endopening of the bore 122 constitutes the outlet 124 for the guidewire108. The shape of the inlet 123 and outlet 124 may be circle or anyshape other than circle such as ellipse and polygon.

The bore 122 does not necessarily have a constant inside diameter overits total length. The illustrated bore 122 changes in inside diametersuch that the inside diameter gradually increases near the proximal endin going toward the proximal end. This structure facilitates easyinsertion of the guidewire 108 into the bore 122 through the inlet 123.

The inside diameter of the bore 122 should be large enough for theguidewire 108 to pass through. To be concrete, it should preferably beabout 0.4 to 1.5 mm, more preferably about 0.9 to 1.3 mm.

The inside diameter (the minimum inside diameter) of the distal end ofthe bore 122 should preferably be slightly larger than the outsidediameter of the guidewire 108, so that a clearance is left between theinside of the bore 122 and the outside of the guidewire 108. Thisstructure helps straighten adequately the curved tip of the guidewire108.

The tubular member 102 may be made of a stiff but somewhat resilientmaterial, such as polyolefin (polyethylene and polypropylene),polyamide, polycarbonate, polyester (polyethylene terephthalate andpolybutylene terephthalate), polyurethane, SEBS resin, fluorocarbonresin, and thermoplastic elastomer (polyolefin elastomer, polyamideelastomer, polyester elastomer, and polyurethane elastomer). They may beused alone or in combination with one another in the form of polymeralloy or laminated composite material.

The tubular member 102 has a slit 103 formed over its total length. Theslit 103 penetrates the wall of the tubular member 102. The slit 103 isstraight in its plan view (FIG. 8).

The slit 103 facilitates insertion of the guidewire 108 because it openswhen the guidewire 108 is inserted into the bore 122 of the tubularmember 102.

As shown in FIG. 9, the slit 103 has a straight cross section. In otherwords, it should tightly close over the entire distance from the bore122 of the tubular member 102 to the outside of the tubular member 102.Alternatively, the slit 103 may have a Y- or V-shaped cross section, inwhich case it closes only at the bore side.

The slit 103 prevents the guidewire 108 from escaping from the bore 122unexpectedly after the guidewire 108 has been inserted into the bore122, because it tightly closes at least partly across the thickness ofthe wall.

As shown in FIG. 8, the slit 103 is formed such that its width graduallyexpands toward the proximal end, thereby constituting an aperture 104.The aperture 104 takes on a V-shape in its plan view. The end of theaperture 104 (where the aperture has the maximum width) communicateswith the open space of the open part 105.

The aperture 104 facilitates insertion of the guidewire 108 into thebore 122, because it functions as a starting point for insertion. Inother words, one who wants to insert the guidewire 108 into the insertermay insert the guidewire 108 into the aperture 104 and then push it intothe bore 122. As the guidewire 108 is pushed into the bore 122, the slit103 opens such that opening gradually moves to the distal end.

The aperture 104 is not specifically restricted in its length in thelongitudinal direction (or the longitudinal direction of the tubularmember 102); however, it should be about 5 to 100 mm long, preferablyabout 15 to 50 mm long.

The guidewire inserter 101 has at its proximal end a connector 106 forconnection to the holder tube 109 that accommodates the guidewire 108.

The connector 106 has a C-shaped cross-section (resembling a partly cutcircle), as shown in FIG. 10. The space 162 inside the connector 106receives the guidewire 108. The holder tube 109 is connected to theconnector 106 such that its distal end fits into the space 162 insidethe connector 106 (as shown in FIGS. 7 and 10). The guidewire 108 beingfed from the holder tube 109 enters the space 162 inside the connector106.

The inside diameter of the connector 106 should be slightly smaller thanthe outside diameter of the holder tube 109, so that the space 162slightly expands when the holder tube 109 is connected by fitting to theconnector 106. This constitution ensures the holder tube 109 to firmlyfit and connect to the connector 106.

The space 162 inside the connector 106 is coaxial with the bore 122 ofthe tubular member 102 (with its central axis being indicated by S) asshown in FIG. 7. This constitution permits the guidewire 108 to smoothlypass through the space 162 inside the connector 106, the opening 105,and the inlet 123, and to enter the bore 122 of the tubular member 102.

The shape of the connector 106 is not limited to the illustrated one; itmay have any shape and structure so long as it permits connection to theholder tube 109.

Between the inlet 123 of the tubular member 102 and the connector 106 isan open part 105 at which the bore 122 of the tubular member 102 opens.This open part 105 functions as the guidewire holder that holds theguidewire 108.

As shown in FIG. 11, the open part 105 is a curved plate. However, itmay also take on any shape, such as flat plate or rod.

As shown in FIG. 11, the internal surface 151 of the open part 105should preferably be a concavely curved surface. However, it may also bea flat surface. It permits the guidewire 108 to be slid distal orproximal thereon as the guidewire 108 placed thereon is moved underpressure by a finger.

The internal surface 151 may have a surface treatment that reducesfrictional resistance against the guidewire 108. In this way it ispossible to feed or retract the guidewire 108 smoothly whilestraightening the curved tip 181. This object may be achieved by formingminute surface irregularities (emboss) or grooves (particularly thoseperpendicular to the longitudinal direction) on the internal surface 151or by coating the internal surface 151 with polytetrafluoroethylene orthe like that has a low coefficient of friction.

The inlet 123 of the tubular member 102 is surrounded by a slope 126with a prescribed angle with respect to the central axis S (or theinternal surface 151) of the tubular member 102. The angle α between theslope 126 and the internal surface 151 should preferably be about 60 to170°, more preferably about 80 to 135°, as shown in FIG. 7. Thisconstitution permits the guidewire 108 to be moved distal more smoothly.

As shown in FIGS. 6, 8, and 9, the distal end of the tubular member 102has on its outer surface a pair of protruded rims 107, which project inthe mutually opposite directions with respect to the central axis S ofthe tubular member 102. The protruded rims 107 extend in thelongitudinal direction of the tubular member 102 and projectsymmetrically with respect to the plane containing the slit 103 (thevertical direction in FIG. 9). In other words, the two protruded rims107 are formed at intervals of 180° in the circumferential direction ofthe tubular member 102.

The protruded rims 107 are formed such that they come into contact withand fit to the inner surface of the hub 111 when the distal end of thetubular member 102 is inserted into the hub 111 of the tube 110. Thisconstitution permits stable connection between the tubular member 102and the tube 110. For adequate connection, the protruded rims 107 shouldmeet the following requirements.

The protruded rims 107 should have an outermost surface 171 sloped at aprescribed angle with respect to the central axis S of the tubularmember 102, as shown in FIG. 8. The outermost surface 171 should besloped such that the distal end approaches the central axis S of thetubular member 102. The protruded rims 107 having the sloped outermostsurface 171 ensures stable fitting to the bore of the hub 111, becausethe hub 111 at the proximal end of the tube 110 is usually taperedtoward the distal end as shown in FIG. 12.

The angle β (shown in FIG. 8) between the central axis S of the tubularmember 102 and the outermost surface (or sloped surface) 171 should besubstantially or approximately equal to the taper angle of the taperedbore of the hub 111 into which the tubular member 102 is fitted. Itshould preferably be about 0.5 to 45°, more preferably about 0.8 to 10°,and most desirably 1.6 to 1.8°. This angle conforms to the ISO 594/1Luer taper standard.

The outermost surface 171 of the protruded rims 107 has an arcuateconvex cross section as shown in FIG. 9. This constitution contributesto stable fitting to the bore of the hub 111, which has usually acircular cross section. The convex outermost surface 171 shouldpreferably have a radius of curvature of about one half the insidediameter of the hub 111.

The protruded rims 107 determine the depth of insertion into the tube110. They also align the tubular member 102 with the tube 110, asexplained in the following.

As shown in FIG. 12, the tube 110 includes the hub 111 (which has atapered bore) and the catheter (or puncture needle) 112 (which isconnected to the distal end of the hub 111). The protruded rims 107,with their outermost surfaces 171 formed properly apart, permit thedistal end of the tubular member 102 to stop at an adequate position inthe hub 111 at the time of insertion into the hub 111. Thus, when thetubular member 102 is fit into the hub 111, its distal end is accuratelypositioned. For example, as shown in FIG. 12, the outlet 124 at thedistal end of the tubular member 102 can be made to approximatelycoincide with the position of the opening (shaft inlet) 113 at theproximal end of the catheter 112. Positioning in this manner permits thedistal end of the guidewire 108 fed from the inlet 124 to be insertedinto the catheter 112 smoothly and certainly.

The outermost surfaces 171 of the protruded rims 107 are equally awayfrom the central axis S, so that the central axis of the hub 111approximately coincides with the central axis S of the tubular member102 at the time of insertion into the hub 111.

Thus, when the tubular member 102 is inserted into the hub 111, thecenter of the outlet 124 at the distal end of the tubular member 102approximately coincides with the opening (shaft entrance) 113 at theproximal end of the catheter 112. As the result, the distal end of theguidewire 108, which has been fed from the outlet 124, is inserted intothe catheter 112 smoothly and certainly.

The protruded rims 107 extend in the longitudinal direction of thetubular member 102; however, their length L2 (shown in FIG. 8) is notspecifically restricted. It should be about 2 to 35%, preferably about 5to 20%, of the total length of the guidewire inserter 101. Anexcessively short length L2 would lead to an instable connection to thetube 110 (hub 111), and an excessively long length L2 would makeoperation difficult.

As shown in FIG. 9, which is a sectional view of the tubular member 102,the angle between the two protruded rims 107 and the slit 103 isapproximately 90° in the circumferential direction. This constitutionhelps the slit 103 to open easily and hence facilitates insertion of theguidewire 108 into the bore 122 through the slit 103.

Incidentally, the protruded rims 107 are not limited in shape to thatillustrated above, but they may take on any shape. Moreover, theprotruded rims 107 are not limited in number and arrangement to thoseshown in the drawings. However, it is desirable that they be formed atequal intervals (for example, 120° or 90°) in the circumferentialdirection of the tubular member 102.

The open part 105, the connector 106, and the protruded rims 107 may bemade of any of polyolefin (polyethylene and polypropylene), polyamide,polycarbonate, polyester (polyethylene terephthalate and polybutyleneterephthalate), polyurethane, SEBS resin, fluorocarbon resin, andthermoplastic elastomer (polyolefin elastomer, polyamide elastomer,polyester elastomer, and polyurethane elastomer). They may be used aloneor in combination with one another in the form of polymer alloy orlaminated composite material.

The tubular member 102, the open part 105, the connector 106, and theprotruded rims 107 should preferably be formed integrally from the samematerial; however, they may also be formed from different materialsdiffering in color or may be formed separately and then assembled byadhesion or fusion bonding.

Third Embodiment

FIG. 13 is a side view showing the device for introduction of a longitem according to the third embodiment of the present invention. Thedevice is used as a guidewire inserter. FIGS. 14 and 15 are respectivelya longitudinal sectional view and a plan view of the guidewire insertershown in FIG. 13. FIG. 16 is a sectional view taken along the line A-Ain FIG. 13. FIG. 17 is a sectional view taken along the line B-B in FIG.13. FIG. 18 is a sectional view taken along the line C-C in FIG. 13.

As shown in FIGS. 13 to 18, the guidewire inserter 201 is a tubularmember 202 having a bore 222 (guidewire passage) inside that permits theguidewire, which is a medical long item, to pass through.

The tubular member 202 includes two parts: a cylindrical part (near theproximal end) having an approximately constant outside diameter, and atapered part 221 having a decreasing outside diameter in going to thedistal end. The tapered part 221 facilitates easy and smooth insertionof the guidewire inserter 201 into the sheath or the like (mentionedlater).

Incidentally, the tapered part 221 may be uniformly or stepwise taperedover its total length. Two or more tapered parts may be formed.

The distal end 225 of the tubular member 202 is smaller in outsidediameter than other parts. It may be tapered toward the distal end. Itis inserted into and connected to a puncture needle, catheter, a hub ofa catheter, Y-connector, or a sheath (not shown). It also straightensthe curved tip of the guidewire. Being smaller than other parts,particularly being tapered distal, it facilitates insertion into andconnection to the sheath or the like.

Where it is necessary to connect the tubular member 202 to a device(like Y-connector) in which the space therein branches away, the distalend 225 of the tubular member 102 may be provided with a thin tubularmember having a tapered end (which is prepared separately). Such anadditional tubular member permits the guidewire (with its curved tipstraightened) to be inserted into a Y-connector, while preventing thecurved tip from entering the branch in the Y-connector.

The bore 222 of the tubular member 202 has an approximately circularcross section. The distal end of the bore 222 opens at the distal end ofthe tubular member 202, and the proximal end of the bore 222 opens atthe open part 205 (mentioned later). The proximal end opening of thebore 222 constitutes the inlet 223 for the guidewire, and the distal endopening of the bore 222 constitutes the outlet 224 for the guidewire.The shape of the inlet 223 and outlet 224 may be circle or any shapeother than circle such as ellipse and polygon.

The bore 222 does not necessarily have a constant inside diameter overits total length. The illustrated bore 222 changes in inside diametersuch that the inside diameter gradually increases near the proximal endin going toward the proximal end. This structure facilitates easyinsertion of the guidewire into the bore 222 through the inlet 223.

The inside diameter of the bore 222 should be large enough for theguidewire to pass through. To be concrete, it should preferably be about0.4 to 1.5 mm, more preferably about 0.9 to 1.3 mm.

The inside diameter (the minimum inside diameter) of the distal end ofthe bore 222 should preferably be slightly larger than the outsidediameter of the guidewire, so that a clearance is left between theinside of the bore 222 and the outside of the guidewire. This structurehelps straighten adequately the curved tip of the guidewire.

The tubular member 202 may be made of a stiff but somewhat resilientmaterial, such as polyolefin (polyethylene and polypropylene),polyamide, polycarbonate, polyester (polyethylene terephthalate andpolybutylene terephthalate), polyurethane, SEBS resin, fluorocarbonresin, and thermoplastic elastomer (polyolefin elastomer, polyamideelastomer, polyester elastomer, and polyurethane elastomer). They may beused alone or in combination with one another in the form of polymeralloy or laminated composite material.

The tubular member 202 has a slit 203 formed over its total length. Theslit 203 cuts across the wall of the tubular member 202. The slit 203 isstraight in its plan view (FIG. 15).

The slit 203 facilitates insertion of the guidewire because it openswhen the guidewire is inserted into the bore 222 of the tubular member202.

As shown in FIG. 16, the slit 203 has a straight cross section. In otherwords, it should tightly close over the entire distance from the bore222 of the tubular member 202 to the outside of the tubular member 202.Alternatively, the slit 203 may have a Y- or V-shaped cross section, inwhich case it closes only at the bore side.

The slit 203 prevents the guidewire from escaping from the bore 222unexpectedly after the guidewire has been inserted into the bore 222,because it tightly closes at least partly across the thickness of thewall.

As shown in FIG. 15, the slit 203 is formed such that its widthgradually expands toward the proximal end, thereby constituting anaperture 204. The aperture 204 takes on a V-shape in its plan view. Theend of the aperture 204 (where the aperture has the maximum width)communicates with the open space of the open part 205.

The aperture 204 facilitates insertion of the guidewire into the bore222, because it functions as a starting point for insertion. In otherwords, one who wants to insert the guidewire into the inserter mayinsert the guidewire into the aperture 204 and then push it into thebore 222. As the guidewire is pushed into the bore 222, the slit 203opens such that opening gradually moves to the distal end.

The aperture 204 is not specifically restricted in its length in thelongitudinal direction (or the longitudinal direction of the tubularmember 202); however, it should be about 5 to 100 mm long, preferablyabout 15 to 50 mm long.

The guidewire inserter 201 has at its proximal end a connector 206 forconnection to the holder tube 209 that accommodates the guidewire.

The connector 206 has a C-shaped cross-section (resembling a partly cutcircle), as shown in FIG. 17. The space 262 inside the connector 206receives the guidewire. The holder tube 209 is connected to theconnector 206 such that its distal end fits into the space 262 insidethe connector 206 (as shown in FIGS. 14 and 17). The guidewire being fedfrom the holder tube 209 enters the space 262 inside the connector 206.

The inside diameter of the connector 206 should be slightly smaller thanthe outside diameter of the holder tube 209, so that the space 262slightly expands when the holder tube 209 is connected by fitting to theconnector 206. This constitution ensures the holder tube 209 to firmlyfit and connect to the connector 206.

The space 262 inside the connector 206 is coaxial with the bore 222 ofthe tubular member 202. This constitution permits the guidewire tosmoothly pass through the space 262 inside the connector 206, theopening 205, and the inlet 223, and to enter the bore 222 of the tubularmember 202.

The shape of the connector 206 is not limited to the illustrated one; itmay have any shape and structure so long as it permits connection to theholder tube 209.

Between the inlet 223 of the tubular member 202 and the connector 206 isan open part 205 at which the bore 222 of the tubular member 202 opens.This open part 205 functions as the guidewire holder that holds theguidewire. As shown in FIG. 18, the internal surface 251 of the openpart 205 should preferably be a concavely curved surface or a flatsurface. It permits the guidewire to be slid distal or proximal thereonas the guidewire placed thereon is moved under pressure by a finger.

The internal surface 251 may have a surface treatment that reducesfrictional resistance against the guidewire. In this way it is possibleto feed or retract the guidewire smoothly. This object may be achievedby forming minute surface irregularities (emboss) or grooves(particularly those perpendicular to the longitudinal direction) on theinternal surface 251 or by coating the internal surface 251 withpolytetrafluoroethylene or the like that has a low coefficient offriction.

The inlet 223 of the tubular member 202 is surrounded by a slope 226with a prescribed angle with respect to the central axis (or theinternal surface 251) of the tubular member 202. The angle α between theslope 226 and the internal surface 251 should preferably be about 60 to170°, more preferably about 80 to 135°, as shown in FIG. 14. Thisconstitution permits the guidewire to be moved distal more smoothly.

As shown in FIGS. 15 and 18, the open part 205 has on its both sides apair of wing-like protruded pieces 207, which project in the mutuallyopposite direction from the central axis of the guidewire inserter 201.

The flat protruded pieces 207 help the operator to hold both theguidewire and the guidewire inserter 201 simultaneously with one hand.

The protruded pieces 207 may be curved so that they are fit well withthe operator's fingers. Thus, they help the operator to hold more easilyboth the guidewire and the guidewire inserter 201 simultaneously withone hand.

The protruded pieces 207 may be composed of a curved part and a flatpart, so that the flat part helps the operator to hold both theguidewire and the guidewire inserter 201 simultaneously with one hand ifthe curved part does not fit well with the operator's fingers.

The protruded pieces 207 should have a length L3 (in the longitudinaldirection of the tubular member 202), which is about 10 to 50%,preferably about 20 to 40%, of the total length of the guidewireinserter 201. This length is suitable for easy holding and goodoperation.

The protruded pieces 207 and the open part 205 should preferably beformed in such a way that they partly (preferably more than half, morepreferably entirely) overlap with each other in the longitudinaldirection. This constitution permits the guidewire to be moved distaland proximal (to straighten the curved tip) more easily.

The open part 205, the connector 206, and the protruded prices 207 maybe made of any of polyolefin (polyethylene and polypropylene),polyamide, polycarbonate, polyester (polyethylene terephthalate andpolybutylene terephthalate), polyurethane, SEBS resin, fluorocarbonresin, and thermoplastic elastomer (polyolefin elastomer, polyamideelastomer, polyester elastomer, and polyurethane elastomer). They may beused alone or in combination with one another in the form of polymeralloy or laminated composite material.

The tubular member 202, the open part 205, the connector 206, and theprotruded pieces 207 should preferably be formed integrally from thesame material; however, they may also be formed from different materialsdiffering in color or may be formed separately and then assembled byadhesion or fusion bonding.

Fourth Embodiment

FIG. 19 is a side view showing the device for introduction of a longitem according to the fourth embodiment of the present invention. Thedevice is used as a guidewire inserter. FIGS. 20 and 21 are respectivelya longitudinal sectional view and a plan view of the guidewire insertershown in FIG. 19. FIGS. 22 to 27 are views illustrating how to use theguidewire inserter shown in FIGS. 19 to 21.

As shown in FIGS. 19 to 21, the guidewire inserter 301 is a tubularmember 302 having a bore 322 (guidewire passage) inside that permits theguidewire 314, which is a medical long item, to pass through.

The tubular member 302 includes two parts: a cylindrical part (near theproximal end) having an approximately constant outside diameter, and atapered part 321 having a decreasing outside diameter in going to thedistal end. In this embodiment, the tapered part 321 is formed at thedistal end of the tubular member 302. The tapered part 321 facilitateseasy and smooth insertion of the guidewire inserter 301 into the tube310 (mentioned later).

Incidentally, the tapered part 321 may be uniformly or stepwise taperedover its total length. Two or more tapered parts may be formed. In thisembodiment, the tapered part 321 is formed also near the inlet 323 atthe proximal end of the tubular member 302.

The distal end (or the tapered part 321) of the tubular member 302 isinserted into and connected to the tube 310, such as a puncture needle,a catheter, a hub of a catheter, a Y-connector, or a sheath (not shown).It also straightens the curved tip 315 of the guidewire 314. The tapereddistal end of the tubular member 302 facilitates insertion into andconnection to the tube 310.

The bore 322 of the tubular member 302 has an approximately circularcross section. The distal end of the bore 322 opens at the distal end ofthe tubular member 302, and the proximal end of the bore 322 opens atthe open part 305 (mentioned later). The proximal end opening of thebore 322 constitutes the inlet 323 for the guidewire 314, and the distalend opening of the bore 322 constitutes the outlet 324 for the guidewire314. The shape of the inlet 323 and outlet 324 may be circle or anyshape other than circle such as ellipse and polygon.

The bore 322 does not necessarily have a constant inside diameter overits total length. The illustrated bore 322 changes in inside diametersuch that the inside diameter gradually increases near the proximal endin going toward the proximal end. This structure facilitates easyinsertion of the guidewire 314 into the bore 322 through the inlet 323.

The inside diameter of the bore 322 should be large enough for theguidewire 314 to pass through. To be concrete, it should preferably beabout 0.4 to 1.5 mm, more preferably about 0.9 to 1.3 mm.

The inside diameter (the minimum inside diameter) of the distal end ofthe bore 322 should preferably be slightly larger than the outsidediameter of the guidewire 314, so that a clearance is left between theinside of the bore 322 and the outside of the guidewire 314. Thisstructure helps straighten adequately the curved tip of the guidewire314.

The tubular member 302 may be made of a stiff but somewhat resilientmaterial, such as polyolefin (polyethylene and polypropylene),polyamide, polycarbonate, polyester (polyethylene terephthalate andpolybutylene, terephthalate), polyurethane, SEBS resin, fluorocarbonresin, and thermoplastic elastomer (polyolefin elastomer, polyamideelastomer, polyester elastomer, and polyurethane elastomer). They may beused alone or in combination with one another in the form of polymeralloy or laminated composite material.

The tubular member 302 has a slit 303 formed over its total length. Theslit 303 cuts across the wall of the tubular member 302. The slit 303 isstraight in its plan view (FIG. 21).

The slit 303 facilitates insertion of the guidewire 314 because it openswhen the guidewire 314 is inserted into the bore 322 of the tubularmember 302.

The slit 303 has a straight cross section. In other words, it shouldtightly close over the entire distance from the bore 322 of the tubularmember 302 to the outside of the tubular member 302. Alternatively, theslit 303 may have a Y- or V-shaped cross section, in which case itcloses only at the bore side.

The slit 303 prevents the guidewire 314 from escaping from the bore 322unexpectedly after the guidewire 314 has been inserted into the bore322, because it tightly closes at least partly across the thickness ofthe wall.

As shown in FIG. 21, the slit 303 is formed such that its widthgradually expands toward the proximal end, thereby constituting anaperture 304. The aperture 304 takes on a V-shape in its plan view. Theend of the aperture 304 (where the aperture has the maximum width)communicates with the open space of the open part 305.

The aperture 304 facilitates insertion of the guidewire 314 into thebore 322, because it functions as a starting point for insertion. Inother words, one who wants to insert the guidewire 314 into the insertermay insert the guidewire 314 into the aperture 304 and then push it intothe bore 322. As the guidewire 314 is pushed into the bore 322, the slit303 opens such that opening gradually moves to the distal end.

The aperture 304 is not specifically restricted in its length in thelongitudinal direction (or the longitudinal direction of the tubularmember 302); however, it should be about 5 to 100 mm long, preferablyabout 15 to 50 mm long.

The tubular member 302 has a projection 309 at its distal end. Thisprojection 309 is a distally projecting part of the circumferentialdirection of the tubular member 302. (This part is at the upper side inFIGS. 19 and 20.) This projection 309 takes on a mountain-like shape,with a vertex and slopes, in its plan view (FIG. 21). The slit 303passes through the vertex of the mountain-like shape of the projection309. In other words, the projection 309 is symmetrical with respect tothe slit 303. The projection may also be formed such that the slit 303passes through the slope of the mountain shape.

The projection 309 contributes to strength and prevents the curved tip315 of the guidewire 314 from being caught by the slit 303 when thecurved tip 315 is straightened at the tapered part 321. Therefore, itfacilitates straightening of the curved tip 315 of the guidewire 314 andalso facilitates insertion of the guidewire 314 into the punctureneedle, catheter, or sheath.

The projection 309 is not specifically restricted in the projectinglength in the distal direction; however, the projecting length shouldpreferably be no shorter than 1 mm, more preferably about 1 to 3 mm.

The guidewire inserter 301 has at its proximal end a connector 306 forconnection to the holder tube 316 that accommodates the guidewire 314.

The connector 306 has a C-shaped cross-section (resembling a partly cutcircle). The space 362 inside the connector 306 receives the guidewire314. The holder tube 316 is connected to the connector 306 such that itsdistal end fits into the space 362 inside the connector 306 (as shown inFIG. 20). The guidewire 314 being fed from the holder tuber 316 entersthe space 362 inside the connector 306.

The inside diameter of the connector 306 should be slightly smaller thanthe outside diameter of the holder tube 316, so that the space 362slightly expands when the holder tube 316 is connected by fitting to theconnector 306. This constitution ensures the holder tube 316 to firmlyfit and connect to the connector 306.

The space 362 inside the connector 306 is coaxial with the bore 322 ofthe tubular member 302 (with its central axis being indicated by S) asshown in FIG. 20. This constitution permits the guidewire 314 tosmoothly pass through the space 362 inside the connector 306, theopening 305, and the inlet 323, and to enter the bore 322 of the tubularmember 302.

The shape of the connector 306 is not limited to the illustrated one; itmay have any shape and structure so long as it permits connection to theholder tube 316.

Between the inlet 323 of the tubular member 302 and the connector 306 isan open part 305 at which the bore 322 of the tubular member 302 opens.This open part 305 functions as the guidewire holder that holds theguidewire 314.

The open part 305 is a curved plate. However, it may also take on anyshape, such as flat plate or rod.

The internal surface 351 of the open part 305 should preferably be aconcavely curved surface. However, it may also be a flat surface. Itpermits the guidewire 314 to be slid distal or proximal thereon as theguidewire 314 placed thereon is moved under pressure by a finger.

The internal surface 351 may have a surface treatment that reducesfrictional resistance against the guidewire 314. In this way it ispossible to feed or retract the guidewire 314 smoothly whilestraightening the curved tip 315. This object may be achieved by formingminute surface irregularities (emboss) or grooves (particularly thoseperpendicular to the longitudinal direction) on the internal surface 351or by coating the internal surface 351 with polytetrafluoroethylene orthe like that has a low coefficient of friction.

The inlet 323 of the tubular member 302 is surrounded by a slope 326with a prescribed angle with respect to the central axis S (or theinternal surface 351) of the tubular member 302. The angle α between theslope 326 and the internal surface 351 should preferably be about 60 to170°, more preferably about 80 to 135°, as shown in FIG. 20. Thisconstitution permits the guidewire 314 to be moved distal more smoothly.

As shown in FIGS. 19 and 21, the open part 305 has on its both sides apair of wing-like protruded pieces 308, which project in the mutuallyopposite direction from the central axis of the guidewire inserter 301.

The flat protruded pieces 308 help the operator to hold both theguidewire and the guidewire inserter 301 simultaneously with one hand.

The protruded pieces 308 may be curved so that they are fit well withthe operator's fingers. Thus, they help the operator to hold more easilyboth the guidewire and the guidewire inserter 301 simultaneously withone hand.

The protruded pieces 308 may be composed of a curved part and a flatpart, so that the flat part helps the operator to hold both theguidewire and the guidewire inserter 301 simultaneously with one hand ifthe curved part does not fit well with the operator's fingers.

The protruded pieces 308 should have a length L4 (in the longitudinaldirection of the tubular member 302), which is about 10 to 50%,preferably about 20 to 40%, of the total length of the guidewireinserter 301. This length is suitable for easy holding and goodoperation.

The protruded pieces 308 and the open part 305 should preferably beformed in such a way that they partly (preferably more than half, morepreferably entirely) overlap with each other in the longitudinaldirection. This constitution permits the guidewire to be moved distaland proximal (to straighten the curved tip) more easily.

As shown in FIGS. 19 and 21, the distal end of the tubular member 302has on its outer surface a pair of protruded rims 307, which project inmutually opposite directions with respect to the central axis S of thetubular member 302. The protruded rims 307 extend in the longitudinaldirection of the tubular member 302 and project symmetrically withrespect to the plane containing the slit 303. In other words, the twoprotruded rims 307 are formed at intervals of 180° in thecircumferential direction of the tubular member 302.

The protruded rims 307 are formed such that they come into contact withand fit to the inner surface of the hub 311 when the distal end of thetubular member 302 is inserted into the hub 311 of the tube 310. Thisconstitution permits stable connection between the tubular member 302and the tube 310. For adequate connection, the protruded rims 307 shouldmeet the following requirements.

The protruded rims 307 should have an outermost surface 371, which issloped at a prescribed angle with respect to the central axis S of thetubular member 302, as shown in FIG. 21. The outermost surface 371should be sloped such that the distal end approaches the central axis Sof the tubular member 302. The protruded rims 307 having the slopedoutermost surface 371 ensures stable fitting to the bore of the hub 311,because the hub 311 at the proximal end of the tube 310 is usuallytapered toward the distal end as shown in FIG. 27.

The angle β (shown in FIG. 21) between the central axis S of the tubularmember 302 and the outermost surface (or sloped surface) 371 should besubstantially or approximately equal to the taper angle of the taperedbore of the hub 311 into which the tubular member 302 is fitted. Itshould preferably be about 0.5 to 45°, more preferably about 0.8 to 10°,and most desirably 1.6 to 1.8°. This angle conforms to the ISO 594/1Luer taper standard.

The outermost 371 surface of the protruded rims 307 has an arcuateconvex cross section. This constitution contributes to stable fitting tothe bore of the hub 311, which has usually a circular cross section. Theconvex outermost surface 371 should preferably have a radius ofcurvature of about one half the inside diameter of the hub 311.

The protruded rims 307 determine the depth of insertion into the tube310. They also align the tubular member 302 with the tube 310, asexplained in the following.

As shown in FIG. 27, the tube 310 includes the hub 311 (which has atapered bore) and the catheter (or puncture needle) 312 (which isconnected to the distal end of the hub 311). The protruded rims 307,with their outermost surfaces 371 formed properly apart, permit thedistal end of the tubular member 302 to stop at an adequate position inthe hub 311 at the time of insertion into the hub 311. Thus, when thetubular member 302 is fit into the hub 311, its distal end is accuratelypositioned. For example, as shown in FIG. 27, the outlet 324 at thedistal end of the tubular member 302 can be made to approximatelycoincide with the position of the opening (shaft inlet) 313 at theproximal end of the catheter 312. Positioning in this manner permits thedistal end of the guidewire 314 fed from the inlet 324 to be insertedinto the catheter 312 smoothly and certainly.

The outermost surfaces 371 of the protruded rims 307 are equally awayfrom the central axis S, so that the central axis of the hub 311approximately coincides with the central axis S of the tubular member302 at the time of insertion into the hub 311.

Thus, when the tubular member 302 is inserted into the hub 311, thecenter of the outlet 324 at the distal end of the tubular member 302approximately coincides with the opening (shaft entrance) 313 at theproximal end of the catheter 312. As the result, the distal end of theguidewire 314, which has been fed from the outlet 324, is inserted intothe catheter 312 smoothly and certainly.

The protruded rims 307 extend in the longitudinal direction of thetubular member 302; however, their length L5 (shown in FIG. 21) is notspecifically restricted. It should be about 2 to 35%, preferably about 5to 20%, of the total length of the guidewire inserter 301. Anexcessively short length L5 would lead to an instable connection to thetube 310 (hub 311), and an excessively long length L5 would makeoperation difficult.

The angle between the two protruded rims 307 and the slit 303 isapproximately 90° in the circumferential direction. This constitutionhelps the slit 303 to open easily and hence facilitates insertion of theguidewire 314 into the bore 322 through the slit 303.

Incidentally, the protruded rims 307 are not limited in shape to thatillustrated above, but they may take on any shape. Moreover, theprotruded rims 307 are not limited in number and arrangement to thoseshown in the drawings. However, it is desirable that they be formed atequal intervals (for example, 120° or 90°) in the circumferentialdirection of the tubular member 302.

The open part 305, the connector 306, the protruded rims 307, and theprotruded pieces 308 may be made of any of polyolefin (polyethylene andpolypropylene), polyamide, polycarbonate, polyester (polyethyleneterephthalate and polybutylene terephthalate), polyurethane, SEBS resin,fluorocarbon resin, and thermoplastic elastomer (polyolefin elastomer,polyamide elastomer, polyester elastomer, and polyurethane elastomer).They may be used alone or in combination with one another in the form ofpolymer alloy or laminated composite material.

The tubular member 302, the open part 305, the connector 306, theprotruded rims 307, and the protruded pieces 308 should preferably beformed integrally from the same material. However, they may also beformed from different materials differing in color or may be formedseparately and then assembled by adhesion or fusion bonding.

According to the present invention, the guidewire inserter is used inthe way explained below with reference to FIGS. 22 to 27.

In the first step shown in FIG. 22, the connector 306 of the guidewireinserter 301 is connected to the distal end of the holder tube 316. Theguidewire 314 is fed to distal by pushing it with the finger against theinternal surface 351 of the open part 305, while holding the open part305 and the protruded pieces 308 with one hand.

In the next step shown in FIG. 23, the guidewire 314 is inserted intothe aperture 304, while keeping the curved tip 315 of the guidewire 314at a position beyond the distal end (or the projection 309) of theguidewire inserter 301.

Then, the portion in the aperture 304 of the guidewire 314 is push intothe bore 322 (as indicated by an arrow in FIG. 23), thereby squeezingthe guidewire 314 into the slit 303. The slit 303 is kept opened towardthe distal end, thereby sequentially inserting the guidewire 314 intothe bore 322, as shown in FIG. 24.

The above-mentioned procedure is continued up to the distal end of thetubular member 302, thereby inserting the guidewire 314 into the bore322, as shown in FIG. 25. In this state, the guidewire 314 passesthrough the inlet 323 and the bore 322 and projects in the distaldirection from the outlet 324. The curved tip 315 of guidewire 314,which projects from the outlet 324, retains its curved shape.

In the next step shown in FIG. 26, the guidewire 314 is pulled towardthe proximal end, so that the curved tip 315 is nearly straightened andput in the bore 322. This procedure is carried out by moving theguidewire 314 toward the proximal end, while pushing the guidewire 314with the thumb finger against the internal surface 351 and holding theopen part 305 and the protruded pieces 308 with one hand. During thisprocedure, the projection 309 at the distal end of the tubular member302 prevents the curved tip 315 from being caught by the slit 303. Inthis way it is possible to straighten the curved tip of the guidewire314 easily and certainly.

In the next step shown in FIG. 27, the distal end of the guidewireinserter 3 b 1 is inserted and connected into the bore of the hub 311 ofthe tube 310, while keeping the state shown in FIG. 26. To carry outthis procedure, the guidewire inserter 301 is hold with one hand and thetube 310 with the other hand to move them toward each other.

The tapered part 321 is kept inserting into the hub 311 until theoutermost surface 371 of the protruded pieces 307 come into closecontact with the inside of the hub 311. (This procedure is possiblebecause the inside of the hub 311 is tapered toward the distal end, andthe outermost surface 371 of the protruded pieces 307 is sloped andconvexly curved, as mentioned above.) In this state, the distal end ofthe guidewire inserter 301 is fitted and connected to the tube 310, asshown in FIG. 27. It is to be noted that the outlet 324 at the distalend of the tubular member 302 nearly coincides with the position of theproximal opening 313 (shaft entrance) of the catheter 312, and thecenter of the outlet 324 nearly coincides with the center of theproximal opening 313.

After the guidewire inserter 301 has been fitted and connected to thetube 310, the guidewire 314 is fed to distal in the same way asmentioned above, so that the guidewire projects from the outlet 324 andenters the catheter 312 of the tube 310. As described above, the outlet324 of the tubular member 302 nearly coincides with the proximal opening313 of the catheter 312 and the center of the outlet 324 nearlycoincides with the center of the proximal opening 313. Therefore, theguidewire 314, which has projected from the outlet 324, enters thecatheter 312 smoothly and certainly.

The advantage of this embodiment is that it is possible to connect theguidewire inserter 301 to the tube 310 and to feed the guidewire 314into the catheter 312 easily and certainly because the curved tip 315 ofthe guidewire 314 is adequately straightened.

Fifth Embodiment

FIG. 28 is a sectional side view showing the device for introduction ofa long item according to the fifth embodiment of the present invention.The device is used as a catheter inserter. FIG. 29 is a sectional sideview illustrating how to use the catheter inserter according to thepresent invention (with the curved tip 418 of the catheter 408 insertedinto the bore 422 and straightened). FIG. 30 is a sectional side viewillustrating how to use the catheter inserter according to the presentinvention (with the catheter inserter 401 removed from the catheter408). In what follows, the catheter inserter will be explained withreference to these drawings, with emphases placed on differences fromthe guidewire inserter explained in the first embodiment.

The catheter inserter 401 is a tubular member 402 similar to thatmentioned above, which has therein a bore 422 (guidewire passage) thatpermits the catheter 408, which is the medical long item, to passthrough. The tubular member 402 has a slit 403, an aperture 404, and aprotruded part 405, as in the case mentioned above.

Incidentally, the tubular member 402 may have, on the sides of itsdistal end 425, a pair of protruded rims projecting in the mutuallyopposite directions from its central axis.

The tubular member 402 may also have, on the sides of its proximal end,a pair of wing-like protruded pieces, which project in the mutuallyopposite direction from the central axis of the catheter inserter 401.

In the illustrated case, the catheter 408 inserted into the bore 422 isan angiography catheter of pigtail type (having a curved tip 481 whichis looped). This catheter 408 has a hub 483 at its proximal end.

The catheter inserter according to the present invention should be usedin the following manner.

First, the catheter 408 is inserted into the aperture 404, while placingthe curved tip 481 of the catheter 408 beyond the distal projection 405of the catheter inserter 401.

Next, the part in the aperture 404 of the catheter 408 is pushed intothe bore 422, thereby squeezing the catheter 408 into the slit 403. Thisprocedure causes the slit 403 to gradually open toward the distal endand hence causes the catheter 408 to be sequentially inserted into thebore 422.

The foregoing procedure is continued up to the distal end of the tubularmember 402, thereby inserting the catheter 408 completely into the bore422, as shown in FIG. 28. In this stage, the catheter 408 passes throughthe inlet 423 and the bore 422 and projects from the distal end of theoutlet 424. Then, the curved tip 481 of the catheter 408 projects fromthe distal end of the outlet 424 while keeping its looped shape.

Then, the catheter 408 is pulled toward the proximal end, therebyinserting the curved tip 481 into the bore 242. In this stage, thecurved tip 481 is nearly straightened, as shown in FIG. 29. During thisprocedure, the projection 405 at the distal end of the tubular member402 prevents the curved tip 481 from being caught by the slit 403. Inthis way it is possible to straighten the curved tip 481 of the catheter408 easily and certainly.

The same effect as mentioned above will be produced for catheters of anytype (for example, catheter of Jadkins type and catheter of Amplatztype), regardless of the shape of the curved tip 481 of the catheter408.

The distal end 425 of the catheter inserter 401 is inserted andconnected to the proximal end of the sheath and then the catheter 408 isfed to distal. In this way the catheter 408 is inserted into the sheath.Since the curved tip 481 of the catheter 408 has been straightened, thedistal end 425 is easily and certainly connected to the sheath and thecatheter 408 is fed easily and certainly into the sheath. In the casewhere the distal end 425 of the catheter inserter 401 is inserted intothe proximal of the guidewire catching the blood vessel, the catheter408 can be fed easily and certainly into the blood vessel.

There may be an instance in which the catheter 408 has to be removedfrom the catheter inserter 401, with catheter 408 left in the bore 422of the catheter inserter 401. In this case, the procedure for removal iscarried out as follows because the catheter 408 has the hub 483 at itsproximal end.

As shown in FIG. 30, the catheter 408 is inserted into the aperture 404and squeeze the catheter 408 into the slit 403 while pulling it out ofthe bore 422, so that the slit 403 gradually opens in going toward thedistal end, thereby allowing the catheter 408 to be sequentially removedfrom the bore 422. (The removed catheter 408 is indicated by a dottedline in FIG. 30.)

Since the catheter inserter 401 according to this embodiment has theslit 403, which cuts across the wall of the tubular member 402 over thetotal length of the tubular member 402, it is possible to remove thecatheter 408 from the catheter inserter 401 easily and rapidly.

Incidentally, the catheter to be inserted into the catheter inserter 401is not limited to the angiography catheter mentioned above; but itincludes catheters of any kind and use.

The embodiments mentioned above to illustrate the present invention arenot intended to restrict the scope of the present invention. They may bemodified by replacement with equivalent components or by addition ofother components.

For example, the slit, which is straight in plan views of FIGS. 1, 8,15, and 21, may be totally or partly curved or bent or zigzag.

The device for introduction of a long item, which is covered in thepresent invention, is not limited to the guidewire inserter and catheterinserter mentioned above. It includes any device to introduce a longitem for medical use other than guidewire and catheter.

1. A catheter inserter for straightening a curved tip of a catheter, theinserter being a tubular member having a wall and a bore for passage ofthe catheter, and only a single slit cutting completely through the wallof the tubular member the entire length of the tubular member, whereinthe tubular member comprises a projection at its distal end thatprojects distally beyond circumferentially adjacent portions of thetubular member, and the slit cuts through the projection.
 2. Thecatheter inserter as defined in claim 1, wherein said projectionpossesses a mountain-like shape having a vertex and slopes in a planview, and the slit passes through the vertex or slope of themountain-like shape.
 3. The catheter inserter as defined in claim 1,wherein said tubular member has at its proximal end an apertureresulting from the split expanding towards the proximal end.